Manager, Quality Operations

Amylyx Pharmaceuticals • Cambridge, MA

2d • $129,000 - $145,000 • Remote

About The Position

This position provides CMC quality oversight of drug substance manufacturing, packaging, and distribution. As the CMC quality expert, the role is accountable for ensuring company, regional, and global GMP and GDP standards and regulations are met, and that the CMC Quality department ensures the quality of products and materials produced by Amylyx’s contracted partners.

Amylyx supports remote work opportunities within the United States, subject to restrictions based on health insurance coverage and state tax regulations; applicants residing or working in Alaska or Hawaii are not being considered. The employee will travel to the company’s Cambridge, Massachusetts corporate location several times a year and attend other company-related events as necessary. The remote work setting must provide privacy, reliable internet access, phone service, and the ability to video conference. Travel may be required up to 10% within the United States, potentially including on-site review of third-party operations.

Requirements

• At least 5 years of experience with a bachelor's degree in Pharmaceutical Sciences, or at least 3 years of experience with an advanced degree in Pharmaceutical Sciences.
• At least 3 years of directly related experience with peptide and/or oligonucleotide (ASO) manufacturing, including quality operations, QC, or MSAT.
• Experience authoring and reviewing NDA CMC sections and addressing regulatory filing requirements in FDA cGMP regulations, EudraLex, ICH Guidance, and other biopharma industry guidance and regulations.
• Ability to work with all organizational levels and external contract service providers to ensure compliance with current regulations.
• Ability to work remotely in a setting with privacy, reliable internet access, phone service, and video-conferencing capability.
• Travel may be required up to 10% within the United States.

Nice To Haves

• QC experience.

Responsibilities

• Provide quality oversight of drug substance production activities.
• Review and approve drug substance validation documents, equipment validation documents, master production records, product specifications, analytical method qualification and validation documents, method transfer documents, and stability plans.
• Review executed batch production and QC control records to confirm approved procedures were followed and specifications were met.
• Prepare and/or approve batch disposition packages.
• Review and approve quality system records, including deviations, OOS, change controls, CAPAs, and product quality complaints.
• Lead or participate in internal and external meetings as the Quality SME to ensure quality expectations are met for GMP, GDP, and Good Documentation Practice.
• Write, review, and/or approve SOPs as the QA SME for manufacturing, labeling, packaging, and transportation of late-stage and commercial products.
• Review NDAs and ensure source data and information used in regulatory submissions and validation activities are maintained and traceable.
• Support FDA, EMA, and other regulatory agency inspections.

Benefits

• Eligible employees may receive annual performance-based bonuses and equity awards.
• Comprehensive benefits package designed to support employees’ health, well-being, and financial security.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager